Randomized Placebo-Controlled Biomarker Modulation Trial Using Celecoxib in Premenopausal Women at High Risk for Breast Cancer

Prior to enrollment, a newly participating institution must contact Dr. Brown (Study Coordinator) to confirm that the required study materials can be adequately obtained. Part. must be premenopausal women (see Sect 5.2 for definition). Women with previous hysterectomy who have FSH values consistent w/ institutional normal values for the premenopausal state will be considered premenopausal. Borderline and postmenopausal women are ineligible. Women w/ a previous hysterectomy, FSH levels must be obtained w/i 28 days prior to reg. Must have an elevated risk of breast ca as defined by at least one of the following: Modified Gail model risk at 5 yrs of >/= 1.7% or lifetime risk >/= 20% or >/=20% lifetime risk by the Claus Model, BRCA Pro Model, or Tyrer-Cuzick Model. Parts must have at least one breast available for imagery and bx. Must have and must be willing to allow submission of a baseline mammogram w/ a std density wedge done w/i 7 to 14 days after ending last menstrual period and w/i 7 days prior to reg that shows either normal or benign findings corresponding to a BIRADS score of 1 or 2. Parts. w/ mammograms reported as suspicious for malignancy are ineligible. Parts. w/ prior breast ca who rec'd RT, the mammogram must be performed and reported on the breast that did not undergo RT. Parts must be willing to allow submission of core needle breast material for path review and for analysis. Parts must be willing to allow submission of serum and plasma for biomarker analysis and banking. Parts with LCIS or DCIS must also be willing to allow submission of LCIS or DCIS diag specimen and path report for central path review. Must have INR <= 1.5 and PT/PTT <= IULN obtained w/i 28 d prior to reg. Zubrod PS 0-1. Prior tamoxifen is allowed provided tx is d/c at least 28 days prior to reg. Parts must not have rec'd prior systemic therapy w/ SERMs or AIs, prior chemo or biologic therapy for the tx of any ca w/i 5 yrs; prior RT is allowed but at at least one breast must not have rec'd prior RT. Prior anticoagulant therapy allowed provided therapy d/c at least 7 days prior to reg. Parts on chronic daily aspirin or NSAID or parts tx for more than 7 days w/ NSAID w/i the past month are ineligble. Parts may use intermittent aspirin or NSAIDs (< 10 days/mo). Part must have adequate renal and hepatic function. Parts w/ history of MI, angina, CAD, TIA or history of thrombo. disease or current hypertension are not eligible. Parts w/ know sensitivity to celecoxib and parts allergic to sulfonamides are not eligble; parts who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or NSAID are not eligble. Parts know to be extremely lactose intolerate are not eligible. Parts must not be pregnant or nursing and must have agreed to use an effective contraceptive method. Use of hormone base birth control is permitted but cannot begin while on tx. Switching birth control methods is not encouraged.

CANCER CONTROL CREDIT: 1.0